How to Assess the Measurement Performance of Mobile/Wearable Point-of-Care Testing Devices? A Systematic Review Addressing Sweat Analysis
Recent advances in technologies for biosensor integration in mobile or wearable devices have highlighted the need for the definition of proper validation procedures and technical standards that enable testing, verification and validation of the overall performance of these solutions. Thus, reliable...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-03-01
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| Series: | Electronics |
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| Online Access: | https://www.mdpi.com/2079-9292/11/5/761 |
| _version_ | 1797475341540786176 |
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| author | Sarah Tonello Giulia Abate Michela Borghetti Nicola Francesco Lopomo Mauro Serpelloni Emilio Sardini |
| author_facet | Sarah Tonello Giulia Abate Michela Borghetti Nicola Francesco Lopomo Mauro Serpelloni Emilio Sardini |
| author_sort | Sarah Tonello |
| collection | DOAJ |
| description | Recent advances in technologies for biosensor integration in mobile or wearable devices have highlighted the need for the definition of proper validation procedures and technical standards that enable testing, verification and validation of the overall performance of these solutions. Thus, reliable assessment—in terms of limits of detection/quantitation, linearity, range, analytical and diagnostic sensitivity/specificity, accuracy, repeatability, reproducibility, cross-reactivity, diagnostic efficiency, and positive/negative prediction—still represents the most critical and challenging aspect required to progress beyond the status of feasibility studies. Considering this picture, this work aims to review and discuss the literature referring to the available methods and criteria reported in the assessment of the performance of point-of-care testing (PoCT) devices within their specific applications. In particular, without losing generality, we focused on mobile or wearable systems able to analyze human sweat. In performing this review, the focus was on the main challenges and trends underlined in the literature, in order to provide specific hints that can be used to set shared procedures and improve the overall reliability of the identified solutions, addressing the importance of sample management, the sensing components, and the electronics. This review can contribute to supporting an effective validation of mobile or wearable PoCT devices and thus to spreading the use of reliable approaches outside hospitals and clinical laboratories. |
| first_indexed | 2024-03-09T20:42:49Z |
| format | Article |
| id | doaj.art-78ab3ec33aa74ef9aa00cbdc5bd52633 |
| institution | Directory Open Access Journal |
| issn | 2079-9292 |
| language | English |
| last_indexed | 2024-03-09T20:42:49Z |
| publishDate | 2022-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Electronics |
| spelling | doaj.art-78ab3ec33aa74ef9aa00cbdc5bd526332023-11-23T22:53:35ZengMDPI AGElectronics2079-92922022-03-0111576110.3390/electronics11050761How to Assess the Measurement Performance of Mobile/Wearable Point-of-Care Testing Devices? A Systematic Review Addressing Sweat AnalysisSarah Tonello0Giulia Abate1Michela Borghetti2Nicola Francesco Lopomo3Mauro Serpelloni4Emilio Sardini5Department of Information Engineering, University of Padova, 35131 Padova, ItalyDepartment of Molecular and Translational Medicine, University of Brescia, 25123 Brescia, ItalyDepartment of Information Engineering, University of Brescia, 25123 Brescia, ItalyDepartment of Information Engineering, University of Brescia, 25123 Brescia, ItalyDepartment of Information Engineering, University of Brescia, 25123 Brescia, ItalyDepartment of Information Engineering, University of Brescia, 25123 Brescia, ItalyRecent advances in technologies for biosensor integration in mobile or wearable devices have highlighted the need for the definition of proper validation procedures and technical standards that enable testing, verification and validation of the overall performance of these solutions. Thus, reliable assessment—in terms of limits of detection/quantitation, linearity, range, analytical and diagnostic sensitivity/specificity, accuracy, repeatability, reproducibility, cross-reactivity, diagnostic efficiency, and positive/negative prediction—still represents the most critical and challenging aspect required to progress beyond the status of feasibility studies. Considering this picture, this work aims to review and discuss the literature referring to the available methods and criteria reported in the assessment of the performance of point-of-care testing (PoCT) devices within their specific applications. In particular, without losing generality, we focused on mobile or wearable systems able to analyze human sweat. In performing this review, the focus was on the main challenges and trends underlined in the literature, in order to provide specific hints that can be used to set shared procedures and improve the overall reliability of the identified solutions, addressing the importance of sample management, the sensing components, and the electronics. This review can contribute to supporting an effective validation of mobile or wearable PoCT devices and thus to spreading the use of reliable approaches outside hospitals and clinical laboratories.https://www.mdpi.com/2079-9292/11/5/761biosensorspoint-of-care testing devicemobilewearablevalidation proceduressweat |
| spellingShingle | Sarah Tonello Giulia Abate Michela Borghetti Nicola Francesco Lopomo Mauro Serpelloni Emilio Sardini How to Assess the Measurement Performance of Mobile/Wearable Point-of-Care Testing Devices? A Systematic Review Addressing Sweat Analysis Electronics biosensors point-of-care testing device mobile wearable validation procedures sweat |
| title | How to Assess the Measurement Performance of Mobile/Wearable Point-of-Care Testing Devices? A Systematic Review Addressing Sweat Analysis |
| title_full | How to Assess the Measurement Performance of Mobile/Wearable Point-of-Care Testing Devices? A Systematic Review Addressing Sweat Analysis |
| title_fullStr | How to Assess the Measurement Performance of Mobile/Wearable Point-of-Care Testing Devices? A Systematic Review Addressing Sweat Analysis |
| title_full_unstemmed | How to Assess the Measurement Performance of Mobile/Wearable Point-of-Care Testing Devices? A Systematic Review Addressing Sweat Analysis |
| title_short | How to Assess the Measurement Performance of Mobile/Wearable Point-of-Care Testing Devices? A Systematic Review Addressing Sweat Analysis |
| title_sort | how to assess the measurement performance of mobile wearable point of care testing devices a systematic review addressing sweat analysis |
| topic | biosensors point-of-care testing device mobile wearable validation procedures sweat |
| url | https://www.mdpi.com/2079-9292/11/5/761 |
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